Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Spondylarthritis

Treatments: Other: cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02473315

2015- A00337-42

Details and patient eligibility

About

Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition at a temperature of approximately -110 degrees.

A considerable increase in the popularity of WBC has occurred in rheumatologic patients, despite a lack of evidences of its efficiency.

Because of its interesting anti-inflammatory properties, the investigators think that WBC could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs) and corticosteroids, in patients suffering from axial spondyloarthritis.

This is a proof of concept study.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients suffering from axial spondyloarthritis diagnosed according to ASAS criteria, with sacroiliitis on X-rays or MRI, with active disease (BASDAI > 4/10) despite a stable treatment will be included.

Exclusion criteria

• contra indication to cooling,
• previous WBC treatment,
• no social security cover

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

cryotherapy

Experimental group

Treatment:

Other: cryotherapy

light cryotherapy

Placebo Comparator group

Treatment:

Other: cryotherapy